510(k) · Cleared
ClearedEchocom, Imagecom, Dokucom
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tomtec Imaging Systems GmbH · DQK Computer, Diagnostic, Programmable
Cleared on Jun 16, 2000 after a 24-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 of the 235 devices in its family, counting itself, have a Class I recall. 234 later devices descend from it.
- Decided
- Jun 16, 2000
- Review
- 24 days
- Class
- Class II
- Product code
- DQK
- Recalls
- None
- Predicates
- 0
234 later devices descend from it, 2 citing it directly. 2 of the 235 devices in this family, counting this one, have a Class I recall.
- This deviceK001592 Echocom, Imagecom, DokucomTomtec Imaging Systems GmbH · 2000
- Descendant · cites it directly · 184 of its ownK040546 Image-Arena and Research-Arena ApplicationsTomtec Imaging Systems GmbH · 2004
- Descendant · 2 generations on · 97 of its ownK060992 Syngo US WorkplaceSiemens Medical Solutions · 2006 · Recalled
- Descendant · 3 generations on · 95 of its ownK091286 Syngo US WorkplaceSiemens Medical Solutions USA, Inc. · 2009
- Descendant · 2 generations on · 94 of its ownK071232 Image-Arena Applications and Research-Arena ApplicationsTomtec Imaging Systems GmbH · 2007
- Descendant · 4 generations on · 92 of its ownK130159 Qlab Quantification Software Heart ModelPhilips Health Care · 2013
Showing 5 of 234 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 234 · See all- K040546Image-Arena and Research-Arena ApplicationsTomtec Imaging Systems GmbH · 2004 · cites it directly184descendants
- K060992Syngo US WorkplaceSiemens Medical Solutions · 2006 · 2 generations on97descendants
- K091286Syngo US WorkplaceSiemens Medical Solutions USA, Inc. · 2009 · 3 generations on95descendants
- K071232Image-Arena Applications and Research-Arena ApplicationsTomtec Imaging Systems GmbH · 2007 · 2 generations on94descendants
- K130159Qlab Quantification Software Heart ModelPhilips Health Care · 2013 · 4 generations on92descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K001592 | Echocom, Imagecom, Dokucom | Tomtec Imaging Systems GmbH | 2000 | — |
| +1 | K040546 | Image-Arena and Research-Arena Applications | Tomtec Imaging Systems GmbH | 2004 | — |
| +2 | K060992 | Syngo US Workplace | Siemens Medical Solutions | 2006 | 1 |
| +3 | K091286 | Syngo US Workplace | Siemens Medical Solutions USA, Inc. | 2009 | — |
| +2 | K071232 | Image-Arena Applications and Research-Arena Applications | Tomtec Imaging Systems GmbH | 2007 | — |
| +4 | K130159 | Qlab Quantification Software Heart Model | Philips Health Care | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 8 | 0 |
| 2009 | 4 | 0 |
| 2010 | 1 | 0 |
| 2011 | 7 | 0 |
| 2012 | 6 | 0 |
| 2013 | 9 | 0 |
| 2014 | 2 | 0 |
| 2015 | 6 | 0 |
| 2016 | 2 | 0 |
| 2017 | 10 | 0 |
| 2018 | 9 | 1 |
| 2019 | 13 | 0 |
| 2020 | 25 | 1 |
| 2021 | 13 | 0 |
| 2022 | 20 | 0 |
| 2023 | 19 | 0 |
| 2024 | 20 | 0 |
| 2025 | 32 | 0 |
| 2026 | 21 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
2 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DQK device
- #1 K213682 HemoSphere Advanced Monitor, HemoSphere…score 26.6 · 28 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (234)
See all 2342 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K172258Novasight Hybrid SystemConavi Medical, Inc. · 2018 · 4 generations on · ◆ in the 2018 descendants bar of FIG. 11 Class I recall
- K193183ACIST HDi System, ACIST Kodama Intravascular Ultrasound CatheterAcist Medical Systems, Inc. · 2020 · 7 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K040546 (Tomtec Imaging Systems GmbH, 2004) has gone furthest, with 184 descendants of its own.
How does its category compare?
All DQK devicesDQK Computer, Diagnostic, Programmable: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DQK
23so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · DQK
95in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQK
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DQK
433in 2025
MAUDE reports naming product code DQK, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 13 | 83 | 4 | 18 |
| 2008 | 4 | 70 | 1 | 34 |
| 2009 | 12 | 93 | 2 | 40 |
| 2010 | 9 | 64 | 3 | 49 |
| 2011 | 12 | 69 | 2 | 55 |
| 2012 | 7 | 74 | 3 | 129 |
| 2013 | 13 | 68 | 1 | 180 |
| 2014 | 9 | 90 | 4 | 115 |
| 2015 | 7 | 125 | 2 | 131 |
| 2016 | 15 | 190 | 0 | 340 |
| 2017 | 7 | 146 | 2 | 252 |
| 2018 | 14 | 150 | 6 | 261 |
| 2019 | 15 | 113 | 1 | 218 |
| 2020 | 16 | 123 | 1 | 215 |
| 2021 | 16 | 132 | 1 | 351 |
| 2022 | 19 | 136 | 2 | 319 |
| 2023 | 21 | 133 | 2 | 340 |
| 2024 | 13 | 100 | 24 | 557 |
| 2025 | 22 | 95 | 1 | 433 |
| 2026 | 23 | 151 | 2 | — |
https://510kreport.com/device/K001592 · printed Nov 6, 2026
Cite this page
510(k) Report. “K001592: Echocom, Imagecom, Dokucom.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001592
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026